Senior Rave Clinical Database Programmer

Katalyst-Healthcares-; New York (NY); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst-Healthcares- in New York, NY, seeks a Senior RAVE Clinical Database Programmer to design, develop, validate, and maintain CDMS databases for complex clinical studies.

The role requires deep Medidata Rave experience, including CRF design, edit checks, and data management collaboration. You will lead cross-functional teams, manage timelines, and ensure compliance with TMF standards.

Qualifications

• 6+ years of Medidata Rave programming experience.
• Experience with Medidata Rave Core Configuration, including study setup, environment configuration, user roles, security, and system administration.
• Experience managing URL Administration by configuring and maintaining study URLs, environment access, and application settings to support development, UAT, and production environments.
• Experience creating and maintaining Global Libraries to standardize reusable study components across multiple studies.
• Experience programming edit checks, derivations, and custom functions.
• Experience supporting live studies, database amendments, and change requests.
• Working knowledge of the Software Development Life Cycle (SDLC).
• Strong written and verbal communication skills with the ability to collaborate effectively across cross-functional teams.

Responsibilities

• Serve as the primary owner of study-specific database design within the CDMS (e.g., Medidata Rave; experience preferred).
• Review database specification documents including CRF Specifications and Data Validation Specifications (DVS).
• Build clinical study database CRF screens based on approved CRF Specifications.
• Program edit checks, special actions/functions, custom programs, and derivations per the DVS.
• Plan and coordinate edit check test script development, programming, validation, and UAT activities; produce validation documents for TMF.
• Complete study database updates per Change Request documentation and perform impact analyses and risk assessments.
• Lead and support database migration activities, including live study updates and maintenance.
• Coordinate with CDM, Clinical Operations, Biostatistics, and external vendors to align with timelines and objectives.
• Escalate issues impacting timelines, scope, or quality; communicate risks in meetings.
• Balance multiple study assignments while managing priorities and resource needs.
• Troubleshoot and resolve study build, system integration (IVRS, CTMS), and change requests using appropriate applications.
• Develop advanced custom programs and functionality as required by study specifications.
• Review core deliverables for accuracy, completeness, and compliance across studies.
• Participate in departmental initiatives and knowledge-sharing to promote best practices.
• Develop detailed study execution plans with milestones for programming, testing, and UAT.

Skills

Medidata Rave programming

Medidata Rave Core Configuration

URL Administration

Global Libraries

Edit checks and derivations

UAT planning & validation

Live study migrations

SDLC knowledge

Cross-functional collaboration

Job description

Summary: The Senior RAVE Clinical Database Programmer participates in the design, development, validation, and maintenance of clinical study databases. This individual applies advanced knowledge of CRF design, database configuration, edit check programming, custom programming, reporting, system integrations, and CDMS functionality while partnering closely with Clinical Data Management and cross-functional study teams to support successful clinical trial execution.

Key Responsibilities:

• Serve as the primary owner of study-specific database design within the CDMS (e.g., Medidata Rave; experience preferred), leading clinical database programming activities across multiple studies of complex design.


• Review database specification documents created by study teams, including CRF Specifications and Data Validation Specifications (DVS).


• Build clinical study database CRF screens based on approved CRF Specifications.


• Program edit checks, special actions/functions, custom programs, and derivations in accordance with the DVS.


• Plan and coordinate edit check test script development, programming, validation, and User Acceptance Testing (UAT) activities. Ensure issues are resolved in a timely manner and produce validation documentation for study teams and the Trial Master File (TMF).


• Complete study database updates in accordance with Change Request documentation and procedures, including performing impact analyses and risk assessments for proposed changes.


• Lead and support database migration activities, including live study updates and database maintenance.


• Partner with Clinical Data Management, Clinical Operations, Biostatistics, and external vendors to coordinate clinical database programming activities and ensure alignment with study timelines and objectives.


• Participate in project meetings, contribute to problem-solving discussions, communicate project risks, and proactively **escalate** issues that may impact timelines, scope, or quality.


• Balance multiple study assignments while effectively managing priorities and communicating resource needs.


• Troubleshoot and resolve study build, system integration (e.g., IVRS, CTMS), and change request issues using the appropriate applications.


• Develop advanced custom programs and functionality as required by study specifications.


• Ensure high-quality deliverables by reviewing study-level, program-level, and multi-study core deliverables for accuracy, completeness, and compliance.


• Participate in departmental initiatives, user group meetings, and knowledge-sharing activities to promote best practices and awareness of new system features.


• Develop detailed study execution plans, including programming, testing, and UAT milestones, providing clear visibility into study startup progress and key deliverables.


• Support the ongoing evolution of internal EDC capabilities by serving as a technical resource to cross-functional study teams and helping establish efficient database programming processes.

Required Qualifications:

• 6+ years of Medidata Rave programming experience.


• Experience with Medidata Rave Core Configuration, including study setup, environment configuration, user roles, security, and system administration.


• Experience managing URL Administration by configuring and maintaining study URLs, environment access, and application settings to support development, UAT, and production environments.


• Experience creating and maintaining Global Libraries to standardize reusable study components, including forms, fields, code lists, edit checks, and other configuration objects across multiple studies.


• Experience programming edit checks, derivations, custom functions, and database updates.


• Experience supporting live studies, database amendments, and change requests.


• Working knowledge of the Software Development Life Cycle (SDLC).


• Strong written and verbal communication skills with the ability to collaborate effectively across cross-functional teams.

Preferred Qualifications:

• Extensive experience supporting live study migrations.


• Clinical data management domain knowledge.


• Experience with data flow and data analytics.


• Experience planning and executing formal User Acceptance Testing (UAT).


• Experience supporting sponsor-side Clinical Data Management organizations.